SSRI's harmful to children??

[donmurray]

UK enquiry noted resistance by drug companies to revealing negative details.

Pharmaceutical companies accused of manipulating drug trials for profit

By Jeremy Laurance Health Editor

23 April 2004

The multibillion-pound global pharmaceutical industry is accused today of manipulating the results of drug trials for financial gain and withholding information that could expose patients to the risk of harm.

The stranglehold that the industry exerts over research is causing increasing alarm in medical circles as evidence emerges of biased results, under-reporting and selective publication driven by a market worth more than £10bn a year in the UK.

In cancer, heart disease, mental health and related fields the industry has sponsored trials of new drugs which have held out great promise for patients. But when the same drugs have been tested in independent trials paid for by non-profit organisations - governments, medical institutions or charities - they have yielded different results.

Heart drugs prescribed for abnormal heart rhythm introduced in the late Seventies were estimated to kill more Americans each year by 1990 than the Vietnam War. Yet early evidence which suggested the drugs were lethal, and might have saved thousands, went unpublished.

Expensive new cancer drugs introduced in the last decade and claiming to offer major benefits have increasingly been questioned. Evidence published in the Journal of the American Medical Association showed that 38 per cent of independent studies of the drugs reached unfavourable conclusions about them, compared with just 5 per cent of the studies funded by the pharmaceutical industry.

In the latest case, researchers commissioned by the National Institute for Clinical Excellence (Nice) to develop guidelines for prescribing antidepressant drugs to children, say they were refused access to unpublished trials held by the pharmaceutical companies.

Published evidence suggested that the antidepressant drugs called SSRIs (selective serotonin re-uptake inhibitors) were safe and effective for children.

But when researchers obtained the unpublished evidence by contacting individual researchers who had worked on the trials, a picture emerged of increased risk of suicidal ideas and attempted suicide. Only one drug, Prozac, was safe.

Antidepressants, though not recommended for children, were widely prescribed until last year when the Medicines and Healthcare Products Regulatory Agency (MHRA) issued a warning to doctors, prohibiting their use. This followed safety concerns raised by campaigners and taken up in two BBC televisionPanorama broadcasts.

Writing in The Lancet, the authors say: "On the basis of published evidence alone, we could have considered at least tentatively recommending use of these drugs for children and young people with depression. However, our review of combined published and unpublished data ... suggest that these SSRIs are not efficacious. Moreover a possible increased risk of suicidal ideation, serious adverse events or both, although small, cannot be ignored."

Tim Kendall, from the Royal College of Psychiatrists, said the researchers had been "unnerved" by the possibility that Nice could have issued wrong or harmful advice because it did not have access to the full data.

The same concerns would apply to advice issued about other drugs in other specialist areas, he said. Guidelines were being drawn up for the use of antidepressants in adults based on 1,000 published trials but it was possible there were tens or hundreds of unpublished trials they had not seen.

The Lancet says the possibility that the suicide of a child could be provoked by a supposedly beneficial drug would be a "catastrophe" and the idea of the drug's use being based on "selective reporting of favourable research" should be "unimaginable." It says the story of research into SSRIs in childhood "is one of confusion, manipulation and institutional failure."

It cites an internal GlaxoSmithKline memo, published in the Canadian Medical Association Journal last month, referring to a study of the antidepressant Seroxat (paroxetine) in children. The memo said: "It would be unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine."

Billions of pounds are spent on the basis of published evidence, assembled by organisations such as Nice, The Lancet says. Global sales of GlaxoSmithKline's Seroxat amounted to $4.97bn last year.

Andrew Dillon, chief executive of Nice said: "The institute's ultimate objective is to be given and to be able to use freely all data relevant to the guidance which it is asked to develop. We continue to work to that objective."

The Association of the British Pharmaceutical Industry said it was prevented under Nice's rules from supplying unpublished data for the preparation of clinical guidelines. But, it has set up a register of clinical trials, and regulations to be introduced next month under the European clinical trials directive would make monitoring easier.

24 April 2004 00:39

http://www.telegraph.co.uk

[elkpark]

From the LA Times, April 6, 2004:

FDA Sat on Report Linking Suicide, Drugs

Officials ordered more studies after their own expert found children on antidepressants were twice as likely to show suicidal behavior.

By Elizabeth Shogren, Times Staff Writer

WASHINGTON — Ten months ago, when concerns arose about a possible link between children taking antidepressant drugs and suicide attempts, senior officials at the Food and Drug Administration ordered their leading expert to head up an examination of the evidence.

When the government scientist filed his report last winter, however, his bosses decided to keep it secret — even though it found that children who took the drugs were twice as likely to be involved in serious suicide-related behavior as those who did not.

Instead of revealing the findings, senior FDA officials ordered more studies, which were not expected to be completed until summer. They also squelched plans to have the author, Dr. Andrew Mosholder, present his conclusions to an FDA advisory committee when it took up the issue in February.

And in March, when the agency issued a warning about the possibility of problems for young patients taking the drugs, FDA officials said no conclusive scientific evidence existed on the link between antidepressants and potentially suicidal behavior by children. Officials said they based their action on anecdotal complaints from physicians and families that had been presented to the advisory committee.

They gave no hint that their own chief expert on the subject had examined the results of more than two dozen clinical trials conducted by antidepressant manufacturers, and that he had found an unusually high correlation between their use and potentially suicidal behavior in young patients.

The report still has not been made public, but news of Mosholder's conclusions first surfaced in a CBS News report last week. His findings were detailed in an internal FDA document obtained by the Los Angeles Times and authenticated by government officials.

In defending their decision to hold back Mosholder's report, his superiors questioned the reliability of the data on which he based his conclusions. They suggested drug companies, which manufacture antidepressant drugs and conducted the clinical trials in order to market them, might have been too quick to count some behavior as potentially related to suicide — that is, too quick to raise questions about their products.

Among the kinds of actions the officials said should not necessarily have been counted as potentially suicide-related were instances of children who deliberately cut themselves.

Some FDA officials defended the decision to sit on the report and seek more analysis of the data, but some psychiatrists and congressional leaders were angered that the agency had kept Mosholder silent.

"Evidence that they're suppressing a report like this is an outrage, given the public health and safety issues at stake," said Dr. Joseph Glenmullen, a Harvard psychiatrist who wrote a book on problems with the drugs known as serotonin reuptake inhibitors, which alter brain chemistry to manage depression. "They've been claiming that there's no evidence. Here's the evidence."

There is quite a bit more to the article -- here is the site:

http://www.antidepressantsfacts.com/2004-04-06-FDA-suicide-children-SSRI.htm

[lsyorke, RN]

This has been my sons life for the past 3 months. Withdrawal from paxil is a nightmare!! Finally the "unpublished reports" are being released that shows the statistical increase in suicide that parents have been seeing for years. The actions of the drug companies have put thousands of children in danger!!!! Glaxo clinical trials that were never given to the FDA are now available on the internet and its unbelievable some of the comments.

ie "Target: the effectively manage the dissemination of these data in order to minimise any potential negative commercial impact".

This was following the study that showed Paxil had the same positive effect as a placebo in the study.

Any child on an SSRI is at risk of suicide,uncontrolled anger, aggression especially at a dosage change or abrupt discontinuation.

We as medical professionals need to educate the public, since the doctors have failed miserably.

This information has been available since 1998, but is just coming out to the public now.

Am I angry? Your %$^# right I am. This lack of accountability by drug manufacturers almost killed my son.

http://www.nj.com/business/ledger/index.ssf?/base/business-0/1082702080191780.xml

[fawnsternurse]

I am thrilled that this information is coming to the light.There are tons of Yahoo groups that have been talking about this for years.Now it has finally hit the mainstream public.I can only surmise how this information has been suppressed over these years but I am relieved that people are finally having their awareness increased by the latest information. Thank you all for posting this.

[fawnsternurse]

I am thrilled that this information is coming to the light.There are tons of Yahoo groups that have been talking about this for years.Now it has finally hit the mainstream public.I can only surmise how this information has been suppressed over these years but I am relieved that people are finally having their awareness increased by the latest information. Thank you all for posting this.

[lsyorke, RN]

fawnsternurse, not only has it hit the public,it has hit the Congress. They have launched an investigation into the FDA's lack of response to information regarding SSRI'S. I was shocked to find the statistic that 8% of adolescent admissions to a psych unit are directly related to Paxil side effects and withdrawal.

I've become educated in the last 4 months since my son attempted suicide twice while weaning from Paxil, to say nothing about the akesthesia, aggressive outbursts,"brain zaps" etc...

I'm one of the lucky ones, my son is still alive and off Paxil now completely for 16 days after a 3 month wean. He has a personality again, he smiles, he's involved in life again and no sign of the "panic" that was the original reason for the drug. I was forced to discover this on my own, since after the suicide attempts the psychiatrist dropped us as a patient!

This is the website that started my education process:

http://www.paxilprogress.org

[lsyorke, RN]

fawnsternurse, not only has it hit the public,it has hit the Congress. They have launched an investigation into the FDA's lack of response to information regarding SSRI'S. I was shocked to find the statistic that 8% of adolescent admissions to a psych unit are directly related to Paxil side effects and withdrawal.

I've become educated in the last 4 months since my son attempted suicide twice while weaning from Paxil, to say nothing about the akesthesia, aggressive outbursts,"brain zaps" etc...

I'm one of the lucky ones, my son is still alive and off Paxil now completely for 16 days after a 3 month wean. He has a personality again, he smiles, he's involved in life again and no sign of the "panic" that was the original reason for the drug. I was forced to discover this on my own, since after the suicide attempts the psychiatrist dropped us as a patient!

This is the website that started my education process:

http://www.paxilprogress.org